Efficacy of robot-assisted double-flap techniques with refinements to minimize anastomosis-related complications after proximal gastrectomy.

Purpose: The double-flap technique (DFT) is an anti-reflux reconstruction procedure performed after proximal gastrectomy (PG), but its complexity and high incidence of anastomotic stenosis are problematic. We conducted this study to demonstrate the efficacy of robot-assisted DFT, with refinements, to address these issues.

Methods: Surgical outcomes were compared between the following procedures modified over time at our institution: conventional open DFT (group O, n = 16); early robotic DFT (group RE, n = 19), which follows the conventional open PG approach; and late robotic DFT (group RL, n = 21), which incorporates refinements to the early robotic DFT technique by exploiting more of the robotic capabilities available.

Pre-stroke patient characteristics that influence skeletal muscle quality: A cross-sectional study.

Aim: One of the parameters that is measurable using bioelectrical impedance is the phase angle (PhA), which is an indicator of skeletal muscle quality. The PhA reflects cellular health and nutritional status and is an important parameter for monitoring recovery after stroke. However, the factors affecting skeletal muscle quality remain unclear.

Risk Factors Causing Hypothyroidism in Patients With Head and Neck Cancer After Radiotherapy Using SIB-VMAT.

Background/aim: We evaluated the incidence of radiation-induced hypothyroidism and its risk factors in patients with head and neck cancer who underwent radiotherapy using simultaneous integrated boost-volumetric-modulated arc therapy (SIB-VMAT).

Patients And Methods: This retrospective study included 86 patients who received definitive radiotherapy using SIB-VMAT for head and neck cancer. The incidence of ≥ grade 2 hypothyroidism was evaluated.

RAGE in circulating immune cells is fundamental for hippocampal inflammation and cognitive decline in a mouse model of latent chronic inflammation.

Background: Latent chronic inflammation has been proposed as a key mediator of multiple derangements in metabolic syndrome (MetS), which are increasingly becoming recognized as risk factors for age-related cognitive decline. However, the question remains whether latent chronic inflammation indeed induces brain inflammation and cognitive decline.

Methods: A mouse model of latent chronic inflammation was constructed by a chronic subcutaneous infusion of low dose lipopolysaccharide (LPS) for four weeks.

Nocturnal Hypertension and Left Ventricular Diastolic Dysfunction in Patients With Diabetes With the Absence of Heart Failure: Prospective Cohort HSCAA Study.

Background: Diabetes is an important risk factor for heart failure (HF) and is associated with left ventricular (LV) diastolic dysfunction. However, diabetic comorbid conditions, such as nocturnal hypertension, as predictors of diastolic dysfunction are not known in the absence of an HF period. The present study was conducted as the longitudinal examination of the predictive value of nocturnal hypertension profiles on the progression of LV diastolic dysfunction in patients with and without diabetes without HF.

Preoperative higher right ventricular stroke work index increases the risk of de novo aortic insufficiency after continuous-flow left ventricular assist device implantation.

During continuous-flow left ventricular assist device (CF-LVAD) support, hemodynamic shear stress causes a burden on aortic valve (AV) leaflets, leading to de novo aortic insufficiency (AI). This study investigated the influence of preoperative hemodynamic parameters on de novo AI in CF-LVAD recipients. We reviewed 125 patients who underwent CF-LVAD implantation without concomitant AV surgery between 2005 and 2018.

Analysis of particle therapy registries based on a unified treatment policy for esophageal cancer.

This study aimed to evaluate the efficacy and safety of particle therapy (proton beam therapy and carbon-ion radiotherapy) for esophageal cancer by analyzing prospective nationwide registry data from particle therapy facilities throughout Japan. Patients diagnosed with esophageal cancer who received particle therapy between May 2016 and June 2018 were recruited from the registries of 12 particle therapy centers in Japan. Eventually, we enrolled 174 patients who met the inclusion criteria.

Clinical Efficacy and Safety of Nivolumab in Malignant Non-Pleural Mesothelioma: A Multicenter, Open-Label, Single-Arm, Japanese Phase II Trial (Viola) Protocol.

Background: There is no authorized treatment for malignant non-pleural mesothelioma (MNPM) worldwide. In contrast to malignant pleural mesothelioma, MNPM has not been investigated, and no treatment has been established due to its rarity.

Objectives: This multicenter, open-label, single-arm, Japanese phase II trial aims at evaluating the efficacy and safety of nivolumab, an immune checkpoint inhibitor, in advanced or metastatic MNPM treatment.

Novel nomogram developed for determining suitability of metastatic castration-resistant prostate cancer patients to receive maximum benefit from radium-223 dichloride treatment-Japanese Ra-223 Therapy in Prostate Cancer using Bone Scan Index (J-RAP-BSI) Trial.

Purpose: To develop a novel nomogram for determining radium-223 dichloride (Ra-223) treatment suitability for metastatic castration-resistant prostate cancer (mCRPC) patients.

Methods: This Japanese Ra-223 Therapy in Prostate Cancer using Bone Scan Index (J-RAP-BSI) Trial was a retrospective multicenter investigation enrolled 258 mCRPC patients in Japan with Ra-223 treatment between June 2016 and August 2020, with bone scintigraphy findings before treatment, clinical data, and survival outcome available. A nomogram was constructed using prognostic factors for overall survival (OS) based on a least absolute shrinkage and selection operator Cox regression model.

Differentiation of Angiomyolipoma With Minimal Fat from Clear Cell Renal Cell Carcinoma Using Non-contrast Multiparametric Magnetic Resonance Imaging.

Background/aim: This study was conducted to ascertain the optimal combination of non-contrast magnetic resonance (MR) imaging sequences for the differential diagnosis between small angiomyolipoma (AML) with minimal fat and clear cell renal cell carcinoma (CCRCC).

Patients And Methods: Thirty-nine patients with pathologically proven AML with minimal fat (n=6) or CCRCC (n=33) measuring 4 cm or less were included. All underwent MR imaging before partial nephrectomy or percutaneous biopsy.

Blinded sample size re-estimation for comparing over-dispersed count data incorporating follow-up lengths.

Blinded sample size re-estimation (BSSR) is an adaptive design to prevent the power reduction caused by misspecifications of the nuisance parameters in the sample size calculation of comparative clinical trials. However, conventional BSSR methods used for overdispersed count data may not recover the power as expected under the misspecification of the working variance function introduced by the specified analysis model. In this article, we propose a BSSR method that is robust to the misspecification of the working variance function.

Long-term survival after surgical or transcatheter aortic valve replacement for low or intermediate surgical risk aortic stenosis: Comparison with general population.

Background: Long-term survival after surgery for severe aortic stenosis (AS) provides important information regarding the choice between surgical (SAVR) and transcatheter (TAVR) aortic valve replacement. This study investigated the long-term survival of AS patients with low or intermediate surgical risk who underwent SAVR or TAVR in our institution versus that of the Japanese general population.

Methods: From 2009 to 2019, 1276 consecutive patients underwent SAVR or TAVR for severe AS.

Evolocumab for prevention of microvascular dysfunction in patients undergoing percutaneous coronary intervention: the randomised, open-label EVOCATION trial.

Statins have been shown to prevent microvascular dysfunction that may cause periprocedural myocardial infarction after percutaneous coronary intervention (PCI). Evolocumab has more potent lipid-lowering properties than statins.  Aims: The aims of this study were to investigate whether evolocumab pretreatment on top of statin therapy could prevent periprocedural microvascular dysfunction.

Regulatory issues and the potential use of Bayesian approaches for early drug approval systems in Japan.

Bayesian methods quantify and interpret the therapeutic effects of investigational drugs based on probability statements of the posterior distribution. However, the basic principle underlying the use of Bayesian methods in registration trials for new drug applications in Japan has not been adequately discussed. Motivated by the two drug approval systems for early approval recently enacted in Japan, we present our perspectives on the application of the Bayesian approach in registration trials in Japan.

Radiation Pneumonitis After Volumetric Modulated Arc Therapy for Non-small Cell Lung Cancer.

Background/aim: To evaluate the incidence and grade of radiation pneumonitis after volumetric modulated arc therapy (VMAT) performed for the treatment of non-small cell cancer (NSCLC).

Patients And Methods: Fifty consecutive non-surgical candidates with NSCLC underwent VMAT. Thirty-five patients had stage-III tumors and 15 had recurrent tumors.

Potential advantages of robotic total gastrectomy for gastric cancer: a retrospective comparative cohort study.

Laparoscopic total gastrectomy (LTG) is a highly technical surgery that can lead to postoperative complications. Whether the recently introduced robotic surgery overcomes the drawbacks of laparoscopic surgery in total gastrectomy remains controversial. Therefore, we aimed to elucidate the potential benefits of robotic total gastrectomy (RTG) and compare the short-term outcomes of RTG and LTG.

Design and rationale of the EVOCATION trial: A prospective, randomized, exploratory study comparing the effect of evolocumab on coronary microvascular function after percutaneous coronary intervention in patients with stable coronary artery disease.

Percutaneous coronary intervention (PCI) is a standard treatment in patients with stable coronary artery disease (CAD); however, periprocedural myocardial infarction (PMI) remains a common complication of PCI. Aggressive lipid-lowering therapy with statin has shown to reduce the incidence of PMI by preventing coronary microvascular dysfunction. It is unclear whether evolocumab, a potent lipid-lowering agent, could diminish microvascular damage after PCI.

Development and Accuracy Evaluation of Augmented Reality-based Patient Positioning System in Radiotherapy: A Phantom Study.

Background/aim: To develop and evaluate the accuracy of augmented reality (AR)-based patient positioning systems in radiotherapy.

Materials And Methods: AR head-mounted displays (AR-HMDs), which virtually superimpose a three-dimensional (3D) image generated by the digital imaging and communications in medicine (DICOM) data, have been developed. The AR-based positioning feasibility was evaluated.

Four-quadrant visualization of systemic circulatory equilibrium: right ventricular failure after left ventricular assist device implantation.

Right ventricular failure (RVF) is a serious adverse event after left ventricular assist device (LVAD) implantation but difficult to be characterized. This study aimed to visualize the dynamic circulatory equilibrium of acute RVF after LVAD implantation using a new four-quadrant diagram constructed by ) cardiac function with central venous pressure (CVP) and cardiac index (CI) axes, ) arterial vascular resistance with CI and mean blood pressure (mBP) axes, ) pressure-diuretic function with mBP and net urinary sodium output (net U-Na) axes, and ) venous compliance with net U-Na and CVP axes. Twenty LVAD patients were stratified into two groups, (≤10 days) and (>10 days), according to duration of postoperative inotropic support.

Anastomosis behind the sternoclavicular joint is associated with increased incidence of anastomotic stenosis in retrosternal reconstruction with a gastric conduit after esophagectomy.

Anastomotic stenosis after esophagectomy is a major cause of long-term morbidity because it leads to poor dietary intake and malnutrition that markedly reduces the quality of life. The aim of this study was to test the hypothesis that anastomosis behind the sternoclavicular (SC) joint in retrosternal reconstruction is associated with an increased risk of anastomotic stenosis compared with anastomosis deviated from the joint. Among 226 patients who underwent esophagectomy for esophageal cancer between April 2010 and March 2019, we selected 114 patients who underwent retrosternal reconstruction using a gastric conduit for this study.

HLA-Matched Allogeneic iPS Cells-Derived RPE Transplantation for Macular Degeneration.

Immune attacks are key issues for cell transplantation. To assess the safety and the immune reactions after iPS cells-derived retinal pigment epithelium (iPS-RPE) transplantation, we transplanted HLA homozygote iPS-RPE cells established at an iPS bank in HLA-matched patients with exudative age-related macular degeneration. In addition, local steroids without immunosuppressive medications were administered.